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Quality assurance agreement

Quality assurance agreement for distribution of medical products and in-vitro diagnostic products The purpose of these clauses is to ensure compliance with directives and laws relating to marketing of medical products, in-vitro diagnostic products and general laboratory equipment (hereinafter referred to as "products"), by Andreas Hettich GmbH & Co. KG (hereinafter referred to as the "manufacturer"). Achieving that requires the cooperation of all the manufacturer's distributors (hereinafter referred to as "dealers").

Section 1: Legal bases

The following clauses cover distribution, quality assurance, service, market observation and reporting requirements as defined in particular, but not exclusively, by the following directives, laws and standards:

The consolidated 11.10.2007 version of the Directive 93/42 EEC of the European Parliament and Council relating to medical products

The consolidated 7.8.2009 version of the Directive 98/79/EC of the European Parliament and Council relating to in-vitro diagnostic medical devices

The German Medical Products Act in the version announced on 7.8.2002, most recently by Art. 12 of the Act of 24.7.2010 (German Federal Gazette I, p. 983).

The Medical Devices Regulations SOR/98-282 in the consolidated version dated 30.11.2010 published by the Canadian Minister of Justice

The Quality System Regulation from the Code of Federal Regulations (Title 21, Part 820), of the US Food and Drug Administration in the 1.4.2010 version

Where the German Medical Products Act, the German Product Liability Law and the laws, standards and directives stated in the preamble are mentioned in the following provisions, existing medical product laws, directives or binding administrative instructions for the respective contractual territory, present or future, shall also apply.

Section 2: Traceability of medical products

The dealer undertakes to maintain distribution records and retain them at least for the period of time stipulated by the German Medical Products Act and by the relevant national and international directives and the laws, standards and directives stated in the preamble, but at least for 10 years. The following provisions on traceability do not apply within Germany: The distribution records must include detailed information necessary to trace the product. The distribution records must make it possible to conduct corrective and preventive measures, as well as recalls. This proof is required solely to carry out measures pursuant to the German Medical Products Act, the relevant national and international directives, the German Product Liability Law, and the laws, standards and directives stated in the preamble and may only be used by the manufacturer for these purposes. If the dealer does not fulfil these obligations, he shall not be authorized to market the products or must indemnify the manufacturer against any claims arising from marketing of the products. If the dealer incurs costs as a result of traceability of the products and said costs have demonstrably not been included in calculation of the original pricing, the manufacturer shall decide on what share of the costs to bear on a case-by-case basis.

The dealer undertakes to observe the market and products in his contractual territory and to give the manufacturer prompt written notification of any non-compliant products, inadequate safety or effectiveness of the products or restrictions in the product's qualities warranted in the manufacturer's product information. In order to fulfil these obligations pursuant to the German Medical Products Act and the respective directives, the dealer undertakes to install an appropriate quality assurance system such that the manufacturer can take it as a basis for analysing the causes of non-compliant products and develop and implement countermeasures accordingly. Such information must be reported to the manufacturer using the manufacturer's "Claim Report" form.

To enable the manufacturer to comply with the statutory time-limits for reporting such information pursuant to the laws and directives, the dealer must design an appropriate quality assurance system that enables him to report incidents that have impaired the safety or effectiveness of the product to the manufacturer within three working days. Such information must be reported to the manufacturer using the manufacturer's "Claim Report" form. Section 4: Service agreement

(only for subsidiaries and agencies outside Germany) The dealer outside German undertakes to establish and maintain qualified service operations in his contractual territory. This shall include regular service training and certification for his service staff by the manufacturer. The dealer also undertakes to maintain an adequate stock of spare parts for the number of sold devices and to return non-compliant components to the manufacturer in accordance with the latter's stipulations, along with a clear description of the fault and traceability to the individual product. This shall also apply after the warranty period for the respective product expires.

The dealer undertakes to comply with the latest applicable service instructions and with the maintenance guidelines of the manufacturer. The dealer also undertakes to comply with all national provisions on medical products and directives for the products, as well as the laws, standards and directives stated in Section 1.

Section 5: National product registrations, regulations and laws

The dealer outside Germany shall be responsible for complying with the national directives and laws applicable to distribution of the products in his respective contractual territories. If necessary, he shall obtain the registrations and approvals necessary or expedient for operating the products from the national authorities of his country in consultation with, on behalf of and, if legally permissible, in the name of the manufacturer in his capacity as local agent. The dealer must inform the manufacturer in writing of any resultant obligations for the manufacturer, stating the text of the directive or law and where it can be found. The dealer has a duty to inform the manufacturer of such completed measures and their scope and period of validity (e.g. product registrations) and provide the manufacturer with the associated proof, such as copies of certificates from public authorities, and, if the manufacturer is the holder of the registration, by means of original documents. Where legally permissible, the dealer assigns all rights from product registrations and product approvals to the manufacturer, who hereby accepts said assignment.

Section 6: Changes that must be reported

The manufacturer undertakes to inform his permanent agencies which have service operations authorized by the manufacturer and have signed the "Quality assurance agreement for the distribution of medical products and in-vitro diagnostic products", as well as its own subsidiaries, of changes to the range of products and accessories and all technical information necessary to ensure proper maintenance and service. This includes in particular updating documents on spare parts, service instructions and information on the compatibility of spare parts in response to technical changes.

Section 7: Data security

The dealer undertakes to maintain confidentiality on all data he receives from manufacturers and purchasers as part of this agreement and also to protect and retain it in accordance with the applicable national data privacy legislation. The data may only be used for the purposes of the agreement and must be retained or made available to the manufacturer for as long as the manufacturer is obliged by the public authorities to save it and for as long as demanded by national data privacy regulations. Section 8: Termination of the business relationship

Since the regulatory and statutory obligations specified in Sections 2 and 3 do not end when the business relationship between the manufacturer and dealer ends, they must be assigned before the business relationship ends.

Consequently, the dealer undertakes to hand over all his customer-related and product quality-related data and records to the manufacturer which the latter requires to continue to fulfil his obligations under Sections 2 and 3 (hereinafter referred to as data) when the business relationship between the dealer and manufacturer ends.

Alternatively, the data can also be passed on to a legal successor of the dealer, provided this company is reliable and has the experience, organizational structures and trained experts required to distribute medical products in order to enter fully into the obligations on the dealer under this agreement. The manufacturer must be informed in writing of the assignment of the obligations under this agreement and the necessary data at least 3 months beforehand. If one or more of the above qualifications is not met, the manufacturer shall have the right to refuse to allow the dealer's legal successor to assume the obligations under this agreement and to refrain from initiating a business relationship relating to further distribution of the products through the dealer's legal successor. In this case, the dealer must surrender the data directly to the manufacturer. In addition, the legal successor must conclude a similar agreement to this one with the manufacturer. The dealer shall transfer the data to its legal successor only after said agreement has been concluded between the legal successor and the manufacturer. Otherwise, the dealer must surrender the data directly to the manufacturer.

The data to be handed over by the dealer may be used only for the purposes specified in Sections 2 and 3 of this agreement, but not for distribution purposes.

Section 9: Subject matter of the qualtiy assurance agreement

"The subject matter of the quality assurance agreement is the general terms and conditions of Hettich in their latest form, which can be viewed on Hettich's homepage at www.hettichlab.com, when the individual products are supplied. Conflicting terms and conditions of purchase or other general terms and conditions are herewith excluded."

Terms and conditions of purchase

1. Terms and conditions of purchase

The present terms and conditions of purchase apply to all our business dealings with the Supplier even if no reference is made to them in subsequent orders. They apply even in cases where the Supplier draws attention to its own terms and conditions, unless we have agreed to these expressly in writing. If we make no comment on the Supplier's deviating terms, they shall be deemed rejected. The confirmation or performance of our order shall be deemed acceptance of the present terms and conditions of purchase.

2. Placement of order

Our orders will be placed in writing. Obvious errors or mistakes in spelling or calculation shall not be binding on us. Verbal covenants and different terms and conditions of the Supplier shall apply only if we have confirmed them in writing. Execution of contracts and amendments to the contract must be in writing. The simple electronic form (Article 127 par. 2 BGB (the German Civil Code) is no acceptable substitute for the written form. What is required here is the qualified electronic form (Article 126 a BGB).

3. Delivery

Deliveries must be acknowledged by us, i.e. our incoming goods department. Acknowledgements of delivery must contain a full description of the delivered goods such as quantity, weight, designation, etc. and specify the receiving department and the destination address. Risk is transferred to us at the receiving department upon our acceptance of the goods. 3a. Long-term Supplier Declaration for preferential pricing Once a year, when requested, the Supplier shall draw up a Long-term Supplier Declaration. It shall be liable for the accuracy of the information given in such Declaration.

4. REACH and RoHS directive

Deliveries must comply with EC Directive 2002/95/EC (RoHS) and EC Directive 2011/65 EU (RoHS II) on the restriction of the use of hazardous substances in electrical and electronic equipment and with Article 59 (1) and Article 33 of Commission Regulation (EC) No. 1907/2006 (REACH).

5. Delivery lead time

If the Supplier encounters any difficulties in manufacturing or in the procurement of materials, or if circumstances occur which are beyond the Supplier's control which are likely to prevent it making delivery to schedule in the specified quality, then the Supplier must inform our purchasing department without delay.

After expiry of a set period of grace, we shall have the right to procure a substitute or a remedy from a third party at the Supplier's expense. This, however, does not release the Supplier from further damages claims on grounds of its failure to adhere to delivery lead times.

6. Withdrawal

In cases of force majeure or other events beyond our control, we may cancel the contract either wholly or in part, or require performance at a later date without the Supplier being entitled to claim damages against us on account of such events.

7. Prices

The agreed unit or lump-sum prices are firm prices and preclude additional charges of any kind whatsoever. Nor do bigger or smaller dimensions than those specified for items give any justification for changing the unit or the lump-sum price.

8. Warranty

The Supplier gives warranty that its deliveries and services are free of defects. Unless otherwise agreed, the warranty period shall be two years. The warranty period commences with the transfer of risk to our customer or on our customer's acceptance. The Supplier waives the right to a defence on grounds of lateness of a complaint of defect.

9. Severability

The contractual agreements and provisions remain fully in force even if particular parts become legally void.

10. Court of jurisdiction

1. The present terms and conditions and the entire contractual relationship between manufacturer and Supplier are subject to the laws of the Federal Republic of Germany. Application of the UN convention on international purchases is barred. 2. To the extent permitted by law, Tuttlingen shall be the exclusive place of jurisdiction for all litigation arising directly or indirectly from the present contractual relationship.

Copyright

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